Cleft Lip and PalatePhase 2NCT00930124
Cleft Orthognathic Surgery Versus Distraction Osteogenesis - Which is Better?
A Phase 2 study testing Orthognathic surgery and Distraction osteogenesis in people with Cleft Lip and Palate and Maxillary Hypoplasia, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Cleft lip and palate patients normally present with a sunken face due to collapse in the middle part of the face and inability of the upper and lower teeth to meet during chewing. This situation constitutes a serious aesthetic and mastication problem. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cleft Lip and Palate, Maxillary Hypoplasia
- What is being tested?
- Orthognathic surgery and Distraction osteogenesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteHong Kong
- Study dates
- Jun 2002to Jan 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Cleft lip and palate patients who required maxillary advancement ranging from 4-10 mm
Who cannot join
- syndromic cases, skeletal maturity not yet reached
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
OMFS, Faculty of Dentistry, The University of Hong Kong
Sai Ying Pun
About this study
Official title: Distraction Versus Orthognathic Surgery - Which One is Better for Cleft Palate Patients
Cleft lip and palate patients normally present with a sunken face due to collapse in the middle part of the face and inability of the upper and lower teeth to meet during chewing. This situation constitutes a serious aesthetic and mastication problem. A single surgical operation known as orthognathic surgery was traditionally performed to move the upper jaw forward to a more normal position and allow chewing function to be regained. However, due to scar tissue from the original surgical repair of the cleft palate, this procedure is known to be unstable causing bone to rapidly go back to its original position. A new concept of moving the upper jaw bone gradually by 1mm per day using a special device attached to the bone called distraction osteogenesis was established in 1996. Animal studies have shown that this technique can produce stable results with minimal relapse. The feasibility of correcting cleft deformities by gradual distraction has been confirmed by our own clinical studies. The aim of this study (which is the first of its kind) is to conduct a prospective randomized controlled study and compare the treatment outcomes of the current standard (orthognathic surgery) with distraction osteogenesis (gradual bone movement). The objectives focus on four aspects: morbidity, stability, speech function and psychological impact. The results from this study will clarify several clinical dilemmas in decision making when choosing whether to use orthognathic surgery or distraction osteogenesis in the treatment of cleft lip and palate patients. In addition, it will also inform our multidisciplinary research team to improve the total care of the cleft lip and palate patients.
Gradual bone distraction of the midface in cleft palate patients is more stable, less detrimental to speech, and no more troublesome to the patient than conventional osteotomy and bone transposition (orthognathic surgery).
Read the detailed description
Maxillary hypoplasia leading to sunken midface is a common developmental problem in CLP patients and is related to a combination of congenital reduction in midfacial growth and the surgical scar from the repair of the cleft palate. Therefore CLP patients commonly present with short midface and narrow hard palate and severe malocclusion.
Conventional orthognathic surgery can advance, expand and lengthen the maxilla to a normal position in relation to the skull and the occlusion. However, such immediate surgical transposition of the cleft maxilla is technically difficult due to the severe deformity demanding large surgical movement and the tension from the palatal scar. Studies have demonstrated that the repositioned maxilla is rather unstable in the long term. In addition, velopharyngeal competence could be compromised by this immediate advancement technique resulting in abnormally nasal speech.
The feasibility of gradual lengthening of the under-developed mandible in syndromal patients by distraction osteogenesis has been proven. The gradual movement of the maxilla activated by the implanted distractors can theoretically overcome the tension from the palatal scar and the soft palate musculature. This may reduce the long term skeletal relapse of the cleft maxilla and the speech distortion. On the other hand, the distraction procedures involve the surgical insertion and removal operations and the retention of the devices over a two month period. This may increase the chance of infection, social inconvenience and ultimately affect the patient's satisfaction.
- Conditions
- Cleft Lip and Palate, Maxillary Hypoplasia
- Being tested
- Orthognathic surgery, Distraction osteogenesis
- Keywords
- cleft lip and palate, distraction osteogenesis, conventional orthognathic surgery, stability, morbidity, soft tissue changes, psychological adjustment, speech changes, velopharyngeal function
- Medical subject headings
- Cleft Lip, Retrognathia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthognathic surgeryProcedure or surgery
Also called cleft osteotomy
Patients with moderate maxillary hypoplasia needing an advancement of 4-10mm
Distraction osteogenesisProcedure or surgery
Also called cleft distraction
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Group 1 will receive Conventional orthognathic surgery Receives: Procedure: Orthognathic surgery |
| 2 | Active comparator | Group 2 will receive distraction osteogenesis Receives: Procedure: Distraction osteogenesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
standardized questionnaires, lateral cephalographs,nasoendoscopy, nasometry
Measured: intra-operative and post-operatively at 2-6 weeks, 2,3,6,months, 1, 2, 3, 4, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2009 (estimated)
- Study startJun 2002
- Primary completionOct 2004
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft Lip and PalateStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Investigators
- Lim K Cheung, BDS, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00930124
- Sponsor's protocol ID
- CLP_DOvsCO
- Status last verified
- Sep 2011
- First submitted
- 21 Jan 2009
- Last updated
- 13 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distraction Versus Orthognathic Surgery - Which One is Better for Cleft Palate Patients
- ClinicalTrials.gov ID
- NCT00930124
- Acronym / sponsor ID
- CLP_DOvsCO
- Conditions
- Cleft Lip and Palate, Maxillary Hypoplasia
- Keywords
- cleft lip and palate, distraction osteogenesis, conventional orthognathic surgery, stability, morbidity, soft tissue changes, psychological adjustment, speech changes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Jun 2002
- Primary completion
- Oct 2004 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 30 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cleft lip and palate patients normally present with a sunken face due to collapse in the middle part of the face and inability of the upper and lower teeth to meet during chewing. This situation constitutes a serious aesthetic and mastication problem. A single surgical operation known as orthognathic surgery was traditionally performed to move the upper jaw forward to a more normal position and allow chewing function to be regained. However, due to scar tissue from the original surgical repair of the cleft palate, this procedure is known to be unstable causing bone to rapidly go back to its original position. A new concept of moving the upper jaw bone gradually by 1mm per day using a special device attached to the bone called distraction osteogenesis was established in 1996. Animal studies have shown that this technique can produce stable results with minimal relapse. The feasibility of correcting cleft deformities by gradual distraction has been confirmed by our own clinical studies. The aim of this study (which is the first of its kind) is to conduct a prospective randomized controlled study and compare the treatment outcomes of the current standard (orthognathic surgery) with distraction osteogenesis (gradual bone movement). The objectives focus on four aspects: morbidity, stability, speech function and psychological impact. The results from this study will clarify several clinical dilemmas in decision making when choosing whether to use orthognathic surgery or distraction osteogenesis in the treatment of cleft lip and palate patients. In addition, it will also inform our multidisciplinary research team to improve the total care of the cleft lip and palate patients.
Gradual bone distraction of the midface in cleft palate patients is more stable, less detrimental to speech, and no more troublesome to the patient than conventional osteotomy and bone transposition (orthognathic surgery).
Detailed description
Maxillary hypoplasia leading to sunken midface is a common developmental problem in CLP patients and is related to a combination of congenital reduction in midfacial growth and the surgical scar from the repair of the cleft palate. Therefore CLP patients commonly present with short midface and narrow hard palate and severe malocclusion.
Conventional orthognathic surgery can advance, expand and lengthen the maxilla to a normal position in relation to the skull and the occlusion. However, such immediate surgical transposition of the cleft maxilla is technically difficult due to the severe deformity demanding large surgical movement and the tension from the palatal scar. Studies have demonstrated that the repositioned maxilla is rather unstable in the long term. In addition, velopharyngeal competence could be compromised by this immediate advancement technique resulting in abnormally nasal speech.
The feasibility of gradual lengthening of the under-developed mandible in syndromal patients by distraction osteogenesis has been proven. The gradual movement of the maxilla activated by the implanted distractors can theoretically overcome the tension from the palatal scar and the soft palate musculature. This may reduce the long term skeletal relapse of the cleft maxilla and the speech distortion. On the other hand, the distraction procedures involve the surgical insertion and removal operations and the retention of the devices over a two month period. This may increase the chance of infection, social inconvenience and ultimately affect the patient's satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Orthognathic surgeryGroup 1 will receive Conventional orthognathic surgery |
| 2 | Active comparator | Procedure: Distraction osteogenesisGroup 2 will receive distraction osteogenesis |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Cleft lip and palate patients who required maxillary advancement ranging from 4-10 mm
Key exclusion criteria (1 listed)
- syndromic cases, skeletal maturity not yet reached
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orthognathic surgeryAlso: cleft osteotomyPatients with moderate maxillary hypoplasia needing an advancement of 4-10mm | Procedure or surgery | 1 |
| Distraction osteogenesisAlso: cleft distraction | Procedure or surgery | 2 |
Primary outcome
standardized questionnaires, lateral cephalographs,nasoendoscopy, nasometry
Time frame: intra-operative and post-operatively at 2-6 weeks, 2,3,6,months, 1, 2, 3, 4, 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lim K Cheung, BDS, PhD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Orthognathic surgery and Distraction osteogenesis in people with Cleft Lip and Palate and Maxillary Hypoplasia, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
standardized questionnaires, lateral cephalographs,nasoendoscopy, nasometry (time frame: intra-operative and post-operatively at 2-6 weeks, 2,3,6,months, 1, 2, 3, 4, 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2011.